Could A Vaccine End The Opioid Epidemic?

Hennepin County researchers are advancing work that could help end the United State's burgeoning painkiller problem.

With prescription opioid abuse skyrocketing in the last 15 years, health officials have been seeking new ways to address the epidemic, including the use of vaccines as a new kind of treatment option. That’s where a Hennepin County Medical Center-funded team of researchers is making strides as they seek to develop a vaccine that can work on addiction to prescription painkillers such as oxycontin.

Under a program directed by the Minneapolis Medical Research Foundation (MMRF), a non-profit subsidiary of the county medical center, a group of local researchers are developing a vaccine designed to provide a new, safer and more effective means to battle the opioid crisis, which claimed 29,500 lives in 2014 via overdoses from prescription drugs and illegal opioids such as heroin.

Led by Marco Pravetoni, an adjunct assistant professor of pharmacology at the U of M Medical School, the vaccine’s inventors describe it as a potentially paradigm-changing alternative to current treatment methods such as the use of methadone and buprenorphine, which themselves are addictive opioids. Indeed, they say, while such medications are readily available, their real or perceived limitations result in only one in five addicts who could potentially benefit actually opting to use them.

An effective vaccine, the Hennepin County team asserts, could greatly reduce that gap.

When present in the blood stream, the vaccine could work by blocking the effects of opioids, including their painkilling properties and the euphoric high they provide, before the drugs can reach the brain. This is accomplished by triggering an immune response that produces antibodies capable of “sequestering” the opioids in serum and other fluids.

In contrast to opioid-based medications such as methadone, vaccines are not addictive and have proven to be free of significant side effects. Also unlike another popular anti-opioid drug, naltrexone, vaccines don't cause depression or paranoia and won't preclude the use of certain opioids for legitimate medical needs such as surgery.

Vaccines, meanwhile, boast a longer duration of action than naltrexone and eliminate the common problem of addicts choosing to skip or stop their medications entirely at some point—a phenomenon which results in very high relapse rates. Vaccines could be used in addition to these medications, thus allowing doctors to tailor treatments for individuals in a way that would offer protection against relapse if patients stop taking their meds.

Pravetoni told TCB the research program, which began nine years ago, is steadily working toward a goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, likely in the near future, which would allow for testing of the vaccine in human clinical trials.

“We’ve reached the point where we’ve hired a contractor (Florida-based Goodwin Biotechnology) to manufacture pharmaceutical-grade quantities of the vaccine that can be tested in humans,” he said. “We are transitioning now from the end of the discovery stage into the late stages of pre-clinical development. This doesn’t mean we’re close to commercialization yet… it’s a long process. But we’re getting ready for clinical trials with the making of pharmaceutical-grade materials.”

Also on the research team are Dr. Paul R. Pentel, an HCMC physician and U of M medical professor; Philip Portoghese, a U of M distinguished professor of pharmacology; and U researcher Morgan Le Naour.

A press release issued by Goodwin Biotechnology last week characterized the MMRF opioid vaccine project as “highly intriguing.” And indeed, the idea of using a biological approach to opioid addiction is one that feels as though that, if truly effective, could make a profound mark on what has turned into a huge market due to the proliferation of the opioid crisis.

In 2014, an estimated 2.5 million people were dependent on heroin and prescription opioid analgesics, with the yearly public cost of substance abuse of all kinds exceeding $700 billion in criminal activities, lost work productivity and health care expenditures, according to the U.S. Drug Enforcement Agency. In response, sales of existing anti-addiction drugs are strong. For instance, Naltrexone, marketed by Alkermes PLC as Vivitrol, logged total net sales of $94.2 million in 2014 in the United States alone.

But anti-opioid vaccines are also a largely unexplored scientific area despite the current severity of the problem, partly because research funders such as the federal government didn’t realize the true crisis proportions of prescription drug abuse until recent years, Pravetoni said.

“Opiate addiction has always been there on the surface, and of course it’s been a problem for decades, but now it’s really in the spotlight because of the dramatic increase in deaths and overdoses,” he said. “We’re benefiting from the fact that NIDA (the U.S. National Institute on Drug Abuse) has always been just as supportive of immunology and biologics such as vaccines as they have been of other methods.”

The Hennepin County vaccine effort has been funded by NIDA to the tune of more than $4.8 million over the course of 2015 and 2016.

U.S. Trademark and Patent Office records show MMRF and the U of M are co-holders of patent application for a form of the vaccine that can be used to treat both addiction to prescription painkillers such as oxycontin and illegal opioids such as heroin.

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